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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Smart Pacifier That Monitors Electrolyte Levels in Saliva Could Prove to Be Beneficial for Vital Care of Infants in Newborn Intensive Care Units

Tiny sensors with Bluetooth technology that measure useful biomarkers may eliminate need for invasive blood draws used for clinical laboratory tests

What if a baby’s pacifier could be used to measure electrolyte levels in newborns? An international research team has developed just such a device, and it has the potential to reduce invasive blood collections required to provide specimens for clinical laboratory testing of critical biomarkers. At the same time, this device may allow continuous monitoring of electrolyte levels with wireless alerts to caregivers.

Developed at Washington State University (WSU) Vancouver with researchers from the United States and South Korea, the wireless bioelectronic pacifier monitors electrolyte levels in newborn intensive care unit (NICU) babies and sends the collected data to caregivers and hospital information systems in real time.

Reliable Information from Consistent Monitoring

Typical blood draws for NICU babies can cause information gaps as they are usually  only performed twice a day. This can be problematic in cases where more frequent monitoring of these biomarkers is required to monitor the infant’s condition.

“We know that premature babies have a better chance of survival if they get a high quality of care in the first month of birth,” said Jong-Hoon Kim, PhD, Associate Professor at the WSU School of Electrical Engineering and Computer Science, in a WSU news release. “Normally, in a hospital environment, they draw blood from the baby twice a day, so they just get two data points. This device is a non-invasive way to provide real-time monitoring of the electrolyte concentration of babies.”

Kim is a co-corresponding author of the WSU study published in the peer-reviewed journal Biosensors and Bioelectronics, titled, “Smart Bioelectronic Pacifier for Real-Time Continuous Monitoring of Salivary Electrolytes.”

The smart pacifier (above) developed by researchers at the Washington State University School of Electrical Engineering and Computer Science—in collaboration with scientists in two South Korean institutions—provides continuous monitoring of sodium and potassium ion levels. This can help detect and prevent potentially dangerous dehydration issues in NICU babies without invasive blood draws for traditional clinical laboratory testing. (Photo copyright: University of Washington.)

How the Smart Pacifier Works

The miniature system developed by the WSU researchers utilizes a typical, commercially available pacifier outfitted with ion-selective sensors, flexible circuits, and microfluidic channels that monitor salivary electrolytes. These flexible, microfluidic channels attract the saliva when the pacifier is in the infant’s mouth which enables continuous and efficient saliva collection without the need for any type of pumping system. The gathered data is relayed wirelessly to caregivers using Bluetooth technology.

When the researchers tested their smart pacifier on infants, they discovered that the results captured from the device were comparable to information obtained from normal blood draws and standard clinical laboratory tests. Kim noted in the press release that technology currently in use to test infant saliva for electrolytes tend to be bulky, rigid devices that require a separate sample collection.

“You often see NICU pictures where babies are hooked up to a bunch of wires to check their health conditions such as their heart rate, the respiratory rate, body temperature, and blood pressure,” said Kim in the press release. “We want to get rid of those wires.”

The researchers intend to make the components for the device more affordable and recyclable. They also plan to perform testing for their smart pacifier on larger test groups to prove efficacy and hope the gadget will help make NICU treatment less disruptive for infant patients.

Co-authors on the WSU study include researchers from the Georgia Institute of Technology, and Pukyong National University and Yonsei University College of Medicine in South Korea.

Before the ‘Smart’ Pacifier Were ‘Smart’ Diapers!

Going as far back as 2013, Dark Daily has covered research into the use of sensors placed in wearables and disposables to detect and monitor health issues.

In “New ‘Smart Diaper’ Tests Baby’s Urine for Urinary Tract Infections, Dehydration, and Kidney Problems—then Alerts Baby’s Doctor,” Dark Daily reported on how the advent of digital technology and smartphones was moving medical laboratory testing out of the central laboratory and into the bedside, homes, and into diapers!

And this past fall, in “Researchers in Japan Have Developed a ‘Smart’ Diaper Equipped with a Self-powered Biosensor That Can Monitor Blood Glucose Levels in Adults,” we reported on researchers who were combining diagnostics with existing products to help medical professionals and patients monitor bodily functions and chronic diseases.

“It should be noted that the ability to put reliable diagnostic sensors in disposables like diapers has been around for almost a decade and does not seem to have caught on with either caregivers or the public,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication, The Dark Report. “Because the researchers who developed the pacifier are attempting to solve a problem for NICU babies, this solution might find acceptance.”

This is another example of how researchers are thinking outside the box as to how to measure critical biomarkers without the need to send a specimen to the core clinical laboratory and wait hours—sometimes overnight—for results.

JP Schlingman

Related Information:

Smart Pacifier Developed to Monitor Infant Health in Hospitals

Smart Bioelectronic Pacifier for Real-time Continuous Monitoring of Salivary Electrolytes

Researchers in Japan Have Developed a ‘Smart’ Diaper Equipped with a Self-powered Biosensor That Can Monitor Blood Glucose Levels in Adults

New ‘Smart Diaper’ Tests Baby’s Urine for Urinary Tract Infections, Dehydration, and Kidney Problems—then Alerts Baby’s Doctor

Australian Researchers Develop a Superior Genetic Blood or Saliva Test for Detecting Glaucoma in High-risk Individuals

Should the test prove clinically viable, it could lead to new biomarkers for eye disease diagnostics and a new assay for clinical laboratories

Scientists at Flinders University in Australia have developed a genetic blood or saliva test that, they say, is 15 times more effective at identifying individuals at high risk of glaucoma than current medical laboratory tests.

If so, this discovery could lead to new biomarkers for diagnostic blood tests that help medical professionals identify and treat various diseases of the eye. Their test also can be performed on saliva samples. The researchers plan to launch a company later in 2022 to generate an accredited test that can be used in clinical trials.

“Early diagnosis of glaucoma can lead to vision-saving treatment, and genetic information can potentially give us an edge in making early diagnoses, and better treatment decisions,” said lead researcher Owen Siggs, PhD, Associate Professor, College of Medicine and Public Health at Flinders University, in a university press release.

Flinders University researchers have been collaborating with scientists at the QIMR Berghofer Medical Research Institute and other research institutes worldwide for some time to identify genetic risk factors for glaucoma, the press release noted.

The researchers published their findings in the peer-reviewed journal JAMA Ophthalmology, titled, “Association of Monogenic and Polygenic Risk with the Prevalence of Open-Angle Glaucoma.”

“In the cross-sectional study of monogenic and polygenic variants related to the disease, the new genetic test was evaluated in 2,507 glaucoma patients in Australia and 411,337 people with or without glaucoma in the UK. The test, conducted using a blood or saliva sample, could potentially detect individuals at increased risk before irreversible vision loss happens,” Medical Device Network reported.

Jamie Craig, PhD
“Genetic testing is not currently a routine part of glaucoma diagnosis and care, but this test has the potential to change that,” said Jamie Craig, PhD, (above), Distinguished Professor, College of Medicine and Health at Flinders University in Australia and senior author of the study, in a press release. “We’re now in a strong position to start testing this in clinical trials,” he added. This is yet another example of how new research is identifying a novel biomarker that could be incorporated into a clinical laboratory test. (Photo copyright: Flinders University.)

Who Is at Risk for Glaucoma?

Glaucoma is a group of eye diseases that are typically caused by a buildup of pressure within the eye. The eyeball contains and produces a fluid called aqueous humour which provides nutrition to the eye and keeps the eye in a proper pressurized state. Any excess of this fluid should be automatically released via a drainage canal called the trabecular meshwork.

But that’s not always the case. When the fluid cannot drain properly, intraocular pressure is created. Most forms of glaucoma are characterized by this pressure, which can damage the optic nerve and eventually cause vision loss and even blindness. Treatments for the disease include medications, laser treatments, and surgery.

Anyone can develop glaucoma, but according to the Mayo Clinic, individuals at higher risk of the disease include: 

  • Individuals over the age of 60.
  • Those with a family history of glaucoma.
  • People of African, Asian, or Hispanic descent.
  • Patients with certain medical conditions, such as diabetes, heart disease, high blood pressure, and sickle cell anemia.
  • Those with corneas that are thin in the center.
  • Individuals who have had a past eye injury or certain types of eye surgery.
  • People who have taken corticosteroid medications, especially eyedrops, for an extended period of time.

Glaucoma is the second leading cause of blindness worldwide, particularly among the elderly. When diagnosed early, the condition is manageable, but even with treatment, about 15% of glaucoma patients become blind in at least one eye within 20 years.

According to the federal Centers for Disease Control and Prevention (CDC), approximately three million Americans are living with glaucoma. The disease often has no early symptoms, which is why it is estimated that about 50% of individuals who have glaucoma do not realize they have the illness.

Thus, a clinically-viable genetic test that is 15 times more likely to identify people at risk for developing glaucoma in its early stages would be a boon for ophthalmology practices worldwide and could save thousands from going blind.

More research and clinical trials are needed before the Flinders University genetic test for glaucoma becomes available. But the discovery alone demonstrates the importance of continuing research into identifying novel biomarkers that could be incorporated into useful clinical laboratory diagnostic tests.

JP Schlingman

Related Information:

A Game-changer for Glaucoma Diagnosis: Scientists Develop a Blood Test That is 15 Times More Likely than Current Methods to Identify High-risk Individuals Before Irreversible Vision Loss Occurs

Association of Monogenic and Polygenic Risk with the Prevalence of Open-Angle Glaucoma

Flinders University Develops Genetic Test for Glaucoma

The Majority of Glaucoma Cases Remain Undiagnosed in the US

Glaucoma Test ‘Best Yet’

Aqueous Humor Flow and Function

Mayo Clinic: Glaucoma Causes and Symptoms

Glaucoma-Global Clinical Trials Review, H2, 2021

Don’t Let Glaucoma Steal Your Sight!

Human Salivary Proteome Wiki Developed at University of Buffalo May Provide Biomarkers for New Diagnostic Tools and Medical Laboratory Tests

Proteins in human saliva make up its proteome and may be the key to new, precision medicine diagnostics that would give clinical pathologists new capabilities to identify disease

Clinical pathologists may soon have an array of new precision medicine diagnostic tools based on peoples’ saliva. There are an increasing number of “omes” that can be the source of useful diagnostic biomarkers for developing clinical laboratory tests. The latest is the world’s first saliva protein biome wiki.

Called the Human Salivary Proteome Wiki (HSP Wiki), the “public data platform,” which was created by researchers at the University of Buffalo, is the “first of its kind,” according to Labroots, and “contains data on the many thousands of proteins present in saliva.”

The HSP Wiki brings together data from independent studies on proteins present in human saliva. One of the researchers’ goals is to speed up the development of saliva-based diagnostics and personalized medicine tools.

In “The Human Salivary Proteome Wiki: A Community-Driven Research Platform,” published in the Journal of Dental Research, the researchers wrote, “Saliva has become an attractive body fluid for on-site, remote, and real-time monitoring of oral and systemic health. At the same time, the scientific community needs a saliva-centered information platform that keeps pace with the rapid accumulation of new data and knowledge by annotating, refining, and updating the salivary proteome catalog.

“We developed the Human Salivary Proteome (HSP) Wiki as a public data platform for researching and retrieving custom-curated data and knowledge on the saliva proteome. … The HSP Wiki will pave the way for harnessing the full potential of the salivary proteome for diagnosis, risk prediction, therapy of oral and systemic diseases, and preparedness for emerging infectious diseases,” they concluded.

Stefan Ruhl, DDS, PhD and Omer Gokcumen, PhD

“This community-based data and knowledge base will pave the way to harness the full potential of the salivary proteome for diagnosis, risk prediction, and therapy for oral and systemic diseases, and increase preparedness for future emerging diseases and pandemics,” Stefan Ruhl, DDS, PhD (above right, with Omer Gokcumen, PhD, Associate Professor of Biological Sciences on left), Professor, Department of Oral Biology, University of Buffalo, and lead researcher of the study, told Labroots. Development of precision medicine clinical laboratory diagnostics is part of their research goals. (Photo copyright: University of Buffalo.)

Where Does Saliva Come From?

Saliva is a complex biological fluid that has long been linked to oral health and the health of the upper gastrointestinal tract. Only recently, though, have scientists begun to understand from where in the body saliva proteins originate.

The researchers of a study published in Cell Reports, titled, “Functional Specialization of Human Salivary Glands and Origins of Proteins Intrinsic to Human Saliva” sought to better understand the sources of saliva.

The authors wrote: “Salivary proteins are essential for maintaining health in the oral cavity and proximal digestive tract, and they serve as potential diagnostic markers for monitoring human health and disease. However, their precise organ origins remain unclear.

“Through transcriptomic analysis of major adult and fetal salivary glands and integration with the saliva proteome, the blood plasma proteome, and transcriptomes of 28+ organs, we link human saliva proteins to their source, identify salivary-gland-specific genes, and uncover fetal- and adult-specific gene repertoires,” they added.

“Our results pave the way for future investigations into glandular biology and pathology, as well as saliva’s use as a diagnostic fluid,” the researchers concluded.

Saliva plays a crucial role in digestion by breaking down starches. It also provides a protective barrier in the mouth. When salivary glands malfunction, patients can face serious health consequences. Although clinicians and scientists have long understood the importance of saliva to good health, the question now is whether it contains markers of specific diseases.

“The Human Salivary Proteome Wiki contains proteomic, genomic, transcriptomic data, as well as data on the glycome, sugar molecules present on salivary glycoproteins. New data goes through an interdisciplinary team of curators, which ensures that all input data is accurate and scientifically sound,” noted Labroots.

Graphic of whole saliva

The graphic above “shows the interconnectedness of the thousands of salivary proteins originating from blood plasma, parotid glands, and submandibular and sublingual glands. The diagram is one of many tools available to researchers and clinicians through the Human Salivary Proteome Wiki,” noted a UBNow blog post. (Graphic copyright: University of Buffalo.)

Omics and Their Role in Clinical Laboratory Diagnostics 

Proteomics is just one of several hotly-researched -omics that hold the potential to develop into important personalized medicine and diagnostics tools for pathologists. Genomics is a related area of research being studied for its potential to benefit precision medicine diagnostics.

However, unlike genomes, which do not change, proteomes change constantly. That is one of the main reasons studying the human salivary proteome could lead to valuable diagnostics tools.

Combining the study of the -omes with tools like mass spectrometry, a new era of pathology may be evolving. “With the rapid decrease in the costs of omics technologies over the past few years, whole-proteome profiling from tissue slides has become more accessible to diagnostic labs as a means of characterization of global protein expression patterns to evaluate the pathophysiology of diseases,” noted Pathology News.

Saliva and the Age of Precision Medicine

The study of the -omes may be an important element in the evolution of precision medicine, because of its ability to provide information about what is happening in patients’ bodies at the point of care.

In “Precision Medicine: Establishing Proteomic Assessment Criteria from Discovery to Clinical Diagnostics,” study authors Jennifer E. Van Eyk, PhD, Director, Advanced Clinical Biosystems Research Institute in the Department of Biomedical Sciences, and Kimia Sobhani, PhD, Director, ER and Cancer Center Laboratories and Associate Professor, Pathology and Laboratory Medicine, at Cedars-Sinai Medical Center, wrote, “The central goal of precision medicine is to provide the right treatment to the right patient at the right time based on their unique diagnosis/pathophysiological signature. Success relies on development of high-quality biomarkers to assist in diagnosis, prognosis, and risk stratification each patient.”

Thus, a full understanding of the proteome of saliva and what causes it to change in response to different health conditions and diseases could open the door to an entirely new branch of diagnostics and laboratory medicine. It is easy and non-invasive to gather and, given that saliva contains so much information, it offers an avenue of study that may improve patients’ lives.

It also would bring us closer to the age of precision medicine where clinical laboratory scientists and pathologists can contribute even more value to referring physicians and their patients.

Dava Stewart

Related Information:

The Human Salivary Proteome Wiki: A Community-Driven Research Platform

Functional Specialization of Human Salivary Glands and Origins of Proteins Intrinsic to Human Saliva

Researchers Create the First Saliva Wiki

Precision Medicine: Establishing Proteomic Assessment Criteria from Discovery to Clinical Diagnostics

German Scientists Train Dogs to Detect the Presence of COVID-19 in Saliva Samples; Can a Canine’s Nose Be as Accurate as Clinical Laboratory Testing?

Though only in the pilot study phase, results correlate with earlier studies where both dogs and humans were able to “smell” specific diseases in people

Man’s best friend has risked life and limb to save humans for centuries. Now, researchers in Germany have discovered that pooches may be useful in the fight against COVID-19 as well, along with the added benefit that such testing would be non-invasive. In fact, some people believe disease-sniffing dogs may give clinical laboratory testing a run for its money.

Further, even if this approach were not warranted as a clinical diagnostic procedure, trained dogs could be deployed at airports, train stations, sporting events, concerts, and other public places to identify individuals who may be positive for SARS-CoV-2, the coronavirus that causes the COVID-19 illness. Such an approach would make it feasible to “screen” large numbers of people as they are on the move. Those individuals could then undergo a more precise medical laboratory test as confirmation of infections.

In cooperation with Bundeswehr, the German Armed Forces, scientists at the University of Veterinary Medicine Hannover (TiHo), along with scientists from the Hannover Medical School and the University Medical Center Hamburg-Eppendorf, carried out a pilot study with eight specialized sniffer dogs from the Bundeswehr to find people infected with the coronavirus.

After only one week of training, the dogs were able to accurately detect the presence of the infection 94% of the time. 

According to a live interview, which featured Holger Volk, PhD, Department Chair and Clinical Director of the Small Animal Clinic at the University of Veterinary Medicine Hannover and Maren von Köckritz-Blickwede, PhD, Professor of Biochemistry of Infections and Head of Scientific Administration and Biosafety at the Research Center for Emerging Infections and Zoonoses at TiHo, “The samples were automatically distributed at random and neither the dog handlers involved nor the researchers on site knew which samples were positive and which were used for control purposes. The dogs were able to distinguish between samples from infected (positive) and non-infected (negative) individuals with an average sensitivity of 83% and a specificity of 96%. Sensitivity refers to the detection of positive samples. The specificity designates the detection of negative control samples.

The researchers published their findings, “Scent Dog Identification of Samples from COVID-19 Patients—A Pilot Study,” in the open access, peer-reviewed journal BMC Infectious Diseases in July.

In their published study, the authors wrote, “Within randomized and automated 1,012 sample presentations, dogs achieved an overall average detection rate of 94% with 157 correct indications of positive, 792 correct rejections of negative, 33 false positive and 30 false negative indications.” They concluded, “These preliminary findings indicate that trained detection dogs can identify respiratory secretion samples from hospitalized and clinically diseased SARS-CoV-2 infected individuals by discriminating between samples from SARS-CoV-2 infected patients and negative controls. This data may form the basis for the reliable screening method of SARS-CoV-2 infected people.”

In the live interview, Dr. Köckritz-Blickwede said, “We think that this works because the metabolic processes in the body of a diseased patient are completely changed,” adding, “We think that the dogs are able to detect a specific smell of the metabolic changes that occur in those patients.”

Holger Volk, PhD and medical dog an Australian Shepherd
“People have not really realized the potential the dog could have to detect disease from lung-diseased patients,” said Holger Volk, PhD (above with his dog Jo), Department Chair and Clinical Director of the Small Animal Clinic at the University of Veterinary Medicine Hannover and one of the authors of the paper, in a live interview. (Photo copyright: University of Veterinary Medicine Hannover.)

Using Dogs as Part of Clinical Laboratory Testing

The American Kennel Club (AKC) estimates that a dog’s sense of smell is 10,000 to 100,000 times greater than that of humans. This gives dog’s the ability to detect diseases in early stages of development.

“The next steps will be that we try to differentiate between sputum samples from COVID patients versus other diseases, like, for example from influenza patients,” said Köckritz-Blickwede. “That will be quite important to be able to differentiate that in the future.” 

“This method could be employed in public areas such as airports, sport events, borders or other mass gatherings as an addition to laboratory testing, helping to prevent further spreading of the virus or outbreaks,” the live interview description states.

During a pandemic, employers might be able to use dogs to screen employees as they arrive for work. Dogs also could be used as an alternative or in addition to clinical laboratory testing to help prevent the spread of COVID-19. But more work must be done.

“What has to be crystal clear is that this is just a pilot study,” said Volk.  “So, there is a lot of potential to take this further to really make it possible to use these dogs in the field.”

An article on the VCA Hospitals website, titled, “How Dogs Use Smell to Perceive the World,” states that dogs devote much of their brain power to the interpretation of smells and they have more than 100 million sensory receptor sites located in their nasal cavity.

By contrast, humans have only six million sensory receptor sites in their nasal cavity. The area of a dog’s brain that is dedicated to the analysis of odors is about 40 times larger than the comparable part of a human brain and dogs are capable of detecting odors thousands of times better than humans.

The article also further explains how dog’s olfactory glands are very unique when compared to other animals and humans. “Unlike humans, dogs have an additional olfactory tool that increases their ability to smell. Jacobson’s organ is a special part of the dog’s olfactory apparatus located inside the nasal cavity and opening into the roof of the mouth behind the upper incisors. This amazing organ serves as a secondary olfactory system designed specifically for chemical communication.

“The nerves from Jacobsen’s organ lead directly to the brain and are different from the other nerves in the nose in that they do not respond to ordinary smells. In fact, these nerve cells respond to a range of substances that often have no odor at all. In other words, they work to detect “undetectable” odors.”

VCA Hospitals is a chain of veterinary hospitals with more than 1,000 facilities located in 46 states and five Canadian provinces. 

C. diff-sniffing Beagle Dog
Could dogs help prevent hospital-acquired infections? It is an interesting question, and one that has been asked before. In “C. diff-sniffing Beagle Dog Could Lead to Better Infection Control Outcomes in Hospitals and Nursing Homes,” January 2013, Dark Daily reported on a beagle named Cliff (above), which could sniff out Clostridium difficile (C. diff), a potentially deadly bacteria. In a study conducted by researchers at Vrije University Medical Center (VUMC) in Amsterdam, Cliff detected C. diff in both stool samples and the air surrounding infected patients in hospitals. In one test, Cliff correctly identified 50 out of 50 stool samples that were C. diff positive. He correctly identified 47 of 50 negative samples. That’s a sensitivity rate of 100% and a specificity rate of 94%. (Photo copyright: ABC News.)

Dogs are amazing, that’s for sure. But for canines to become widely used to detect infections there would have to be a way to validate each dog’s ability to detect diseases, so that the diagnostics would be consistent across all the dogs being used.

So, while there appears to be potential for utilizing a dog’s uncanny sense of smell to detect disease—including COVID-19—more research is needed before development of clinical testing can take place.  And, perhaps, a set of canine billing codes.

—JP Schlingman

Related Information:

Dogs Are Able to Detect Presence of Coronavirus by Sniffing Human Saliva, New Study Finds

Trained Dogs Were able to Sniff Out Covid-19 Infections with 94% Accuracy: Study

Scent Dog Identification of Samples from COVID-19 Patients – a Pilot Study

Dogs Detecting Disease: Meet America’s Cancer-Sniffing Canines

How Dogs Use Smell to Perceive the World

Live Interview: Diagnoses by Dog Noses—Dogs Can Sniff Out Patients with COVID-19

C. diff-sniffing Beagle Dog Could Lead to Better Infection Control Outcomes in Hospitals and Nursing Homes

Woman Who Can Smell Parkinson’s Disease in Patients Even Before Symptoms Appear May Help Researchers Develop New Clinical Laboratory Test

How One Company’s Saliva Spit Tubes Dominate the DNA Collection Device Market by Maintaining Specimen Integrity for as Long as Two Years

From point-of-care diagnostic tests to ancestral DNA home-testing, this company’s spit tubes are used by more medical laboratories than any other brand

Most clinical laboratory specialists know that OraSure Technologies of Bethlehem, Pa., was the first company to develop a rapid point-of-care DNA diagnostic test for HIV back in the 1990s. This was a big deal. It meant physicians could test patients during office visits and receive the results while the patients were still in the office. Since many patients fail to follow through on doctors’ test orders, this also meant physicians were diagnosing more patients with HIV than ever before.

Today, OraSure is the dominant company in the spit tube industry. OraSure claims its tubes contain patented chemical preservatives that can maintain the specimen’s integrity for up to two years at room temperature. That’s a long time. And this one feature has made OraSure popular with direct-to-consumer (DTC) genetic home-test developers.

OraSure provides nearly all of the specimen receptacles used by individuals searching for their ancestral roots. It’s estimated that about 90% of the DTC genetic-testing market uses the company’s spit tubes. This is partly because OraSure makes the only tubes approved by the US Food and Drug Administration (FDA) for home DNA-testing purposes. 

“The FDA approval gives customers confidence,” Mark Massaro, Managing Director, Senior Equity Analyst at investment bank Canaccord Genuity Group, told Bloomberg. “That, and they can preserve saliva for a long time.”

The OraSure spit tube above contains a patented mix of chemicals that can maintain saliva’s integrity for up to two years at room temperature. This is critical for ensuring specimens arrive at medical laboratories in usable condition to produce accurate test results. (Photo copyright: Zhongjia Sun/Bloomberg Businessweek.)

Spit, Close, Recap, Send

To use the saliva-testing DNA kits, an individual first spits into the tube and then snaps the cap on the tube shut. This action perforates a membrane which contains a patented, chemical mix of preservatives. These chemicals help preserve the sample and minimize contamination from non-human DNA that may be present.

“You’ve got to make it as easy as possible for a person to spit in the tube, close the tube, recap the tube, and send it to you without any variation,” Stephen Tang, PhD, President and Chief Executive Officer at OraSure, told Bloomberg

Saliva samples are very susceptible to environmental factors like temperature and are extremely time sensitive. They need to be properly handled and stored to prevent any degradation and ensure the most accurate test results. Once in the spit tube, a saliva sample can last more than two years at room temperature, according to the company. 

“That’s the secret,” Tang stated. “Saliva is not pure. It’s got a lot of bacteria and other stuff swimming in it.”

OraSure reported the company made $182 million in revenue in 2018, with about $20 million of that amount being profit. DNA Genotek, Inc., a subsidiary of OraSure designed the T-shaped spit tubes being used for consumer-DNA testing kits.

Other Clinical Laboratory Uses for Specimen-Collection Devices

In addition to the consumer-DNA industry, OraSure’s tube technology is used in clinical and academic laboratory situations as well as in veterinary DNA testing. The company is focused on expanding the uses for their specimen-collection technology. They have recently begun using their technology to collect urine specimens for diagnosing sexually transmitted diseases and other conditions. OraSure also has added devices for feces collection, to better compete in the developing field of microbiome for gut bacteria analysis.  

“We are all about the integrity of the sample collection,” Tang says. “It’s a wide-open field.”

Ancestry Sued by OraSure

In 2017, agreed to pay OraSure $12.5 million to settle a lawsuit which alleged the company had copied OraSure’s patented DNA testing technology to produce their own saliva-based DNA test. 

According to the lawsuit, purchased saliva test kits from DNA Genotek in 2012 and 2013 for the purpose of collecting saliva samples from their customers. In 2013, filed for a patent of their own for an improved variation of the kits reportedly without DNA Genotek’s consent. 

OraSure’s test products include:

OraSure also has devices for substance abuse testing, cryosurgical kits for the testing of skin lesions, and kits for forensic toxicology. 

Maintaining specimen integrity is critical to ensure lab test results are accurate and reproducible. OraSure’s spit tube technology solves the problem of preserving specimens while they are transported to clinical laboratories and other pathology facilities. 

—JP Schlingman

Related Information:

One Company Makes Almost All the Home DNA Test Spit Tubes

OraSure Settles Lawsuit with over DNA Testing